Atopic dermatitis
Conditions
Interventions
Study equipment is placed on the evaluation site (symmetrical site near the right and left elbow)
Sponsors
Ibano Kenzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects diagnosed with atopic dermatitis based on Hanifin & Rajka diagnostic criteria.(male or female) 2) Severity: Mild/moderate Eczema Area and Severity Index (EASI) Scores (mild: 1.1-7.0; moderate: 7.1-21.0). 3) Patients with atopic symptoms such as itching and erythema near the right and left elbow joints, and w ho are aware of scratching due to itching 4) Washout conditions Subjects who can refrain from taking oral medications or topical medications for atopic dermatitis [moisturizers, steroids, calcineurin inhibitors, Janus kinase (JAK) inhibitors] from the night before the study. 5) Patients aged 18 years or older who can voluntarily provide their written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients with concomitant skin infection 2) Patients who have no scratching due to itching 3) Patients who are pregnant or breastfeeding 4) Patients whose willingness to continue participating in the study is unclear or those who are judged by the investigator to be unable to participate cooeratively in the study. 5) Patients who are judged by the invetigator to be unable to properly collect data (measurement endpoints) necessary for the study. 6) Patients with metal allergy 7) Patients who are unable to refrain from strenuous exercise before visiting the hospital on the day. 8) Patients who have difficulty participating in the half-sleeve (free at visit, only during the study) 9) Patients with prurigo simplex at the evaluation site. 10) Patients who apply sunscreen to their near the right and left elbow joints, when they visited the study site. 11) Patients who are participating in other clinical studis or clinicals trials. 12) Patients who are assessed as unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in the duration of scratching inhibition (trend assessment of time to initiate scratching after use) 2) Changes in itch score (trend assessment of VAS score). - Confirmation of trend of changes - Immediate effect (check time of abrupt change) - Sustained response (time to return to VAS score of before use) 3) Inspection and photograph of skin condition (check that there is no deterioration of skin condition) 4) Evaluation of safety (to confirm the occurrence of adverse events) 5)Mode evaluation (comparison between cold and warm-cold modes; trend evaluation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comfort mode assessment (change in scratching inhibition in the mode felt comfortable by the study subjects and propensity assessment of the change in itch VAS score-transition) 2) Assessment of usage (Propensity assessment of changes in VAS scores using the stay-use vs slide-use and self-report assessment of ease of use) 3) Sense of control of itching (feeling inhibited from scratching impulse, self-rated sense of tolerance by reporting) 4) Effect Persistence Assessment (self-reported assessment) 5) Assessment as a scratching substitute (self-reported assessment) 6) Comfort/Expectancy in Use (Self-assessment by reporting) | — |
Contacts
Public ContactChiaki Kubota
Osaka Heat Cool Inc.
Outcome results
None listed